title: Pharmacovigilance monitoring of a cohort of pregnant women vaccinated against influenza A(H1N1) variant virus in the Nord-Pas de Calais region of northern France.
abstract: OBJECTIVE
  During the 2009-2010 influenza A variant virus (A(H1N1)v) pandemic in France, a national pharmacovigilance program was set up to monitor vaccinated, pregnant women, especially the reactogenicity of the vaccine and its impact on the outcome of pregnancy and on the newborn. Here, we present the results for the cohort of pregnant women constituted in the Nord-Pas de Calais region of northern France.
  
  
  METHODS
  Vaccinated pregnant women were included in the study by the region's vaccination centers between November 2009 and April 2010.
  
  
  RESULTS
  Eight hundred and six pregnant women were included and 781 were followed up until delivery. The risk of adverse events after vaccination and the maternal, fetal and neonatal medical conditions in our cohort did not appear different from the risk observed in the general population.
  
  
  CONCLUSIONS
  Our results suggest that A(H1N1)v vaccination of pregnant women did not have an adverse impact on the pregnancies' course and outcome.
authors.affiliation: Regional Center of Pharmacovigilance, CRPV, Service de Pharmacologie, CHRU de Lille - 1, place de Verdun, 59045 Lille Cedex, France. Electronic address: marine.auffret@wanadoo.fr.
authors.forename: Marine
authors.initials: M
authors.lastname: Auffret
authors.forename: Johana
authors.initials: J
authors.lastname: Béné
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
authors.forename: Sophie
authors.initials: S
authors.lastname: Moreau-Crépeaux
authors.forename: Jacques
authors.initials: J
authors.lastname: Caron
mesh_terms: D005260:Female; D005602:France; D006801:Humans; D007231:Infant, Newborn; D053118:Influenza A Virus, H1N1 Subtype; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D060735:Pharmacovigilance; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011446:Prospective Studies
chemical_list: D007252:Influenza Vaccines
keywords: Influenza A(H1N1); Influenza vaccine; Neonates; Pharmacovigilance; Pregnancy